Bariatric Surgery and Sperm Quality (BARIASPERM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01842295
First received: February 19, 2013
Last updated: August 2, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men.


Condition Intervention
Obesity
Bariatric Surgery
Other: Blood and sperm samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of total spermatozoids (NTS) variation [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery


Secondary Outcome Measures:
  • Number of total spermatozoids (NTS) variation [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery

  • sperm caracteristics [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery

  • Effect of biological parameters on NTS variation [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery and search of correlation

  • Evaluation of environmental parameters : physical activity [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery

  • Other spermatic parameters : DNA fragmentation [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery

  • Other spermatic parameters : CASA [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery

  • Effect of anthropometric parameters on NTS variation [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery and search of correlation

  • Evaluation of environmental parameters : tobacco consumption [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery

  • Evaluation of environmental parameters : libido [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery

  • Evaluation of environmental parameters : quality of life [ Time Frame: 6 months and 1 year after surgery ] [ Designated as safety issue: No ]
    Comparison before/after surgery


Estimated Enrollment: 45
Study Start Date: February 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Bariatric surgery
Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team
Other: Blood and sperm samples
Blood and sperm samples will be done in each visit

Detailed Description:

In order to assess how bariatric surgery may influence their fertility parameters, patients will attend to 3 visits :

First visit (inclusion, before surgery) :

  • Signature of consent
  • Patient interview (Collection of data on background, treatments, socio-demographic characteristics, social and familial environment, food consumption and habits, tobacco and alcohol use, physical activity, libido and quality of life (surveys))
  • Clinical examination and anthropometric assessment (BMI, blood pressure, expired CO)
  • Blood samples (Metabolic and nutritional plasmatic biomarkers ; Plasmatic oxidative stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation ; sex hormones ; persistent contaminants)
  • Sperm sample (sperm count-morphology ; DNA fragmentation ; CASA)

Bariatric surgery

Second visit (6 month follow-up)

  • Report of adverse events if any
  • Surveys
  • Blood and sperm samples

Third visit (12 month follow-up)

  • Report of adverse events if any
  • Blood and sperm samples
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese men with BMI ≥ 40kg/m² or 35 kg/m² with associated co-morbidities
  • Selected for bariatric surgery by multidisciplinary team
  • From 18 to 50 years old included
  • With a first medical consultation and its results
  • With their written informed consent to participate in the study
  • No problem for understanding verbal or written French
  • An affiliation to social security

Exclusion Criteria:

  • Not candidates for surgery
  • With non idiopathic alteration of spermatogenesis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842295

Contacts
Contact: Sébastien Czernichow, MD +33 1 49 09 55 89 ssebastien.czernichow@apr.aphp.fr
Contact: Laurence Lecomte, PhD +331 58 41 35 45 laurence.lecomte@cch.aphp.fr

Locations
France
Jean Verdier Hospital Recruiting
Bondy, France, 93140
Contact: Rachel Levy, MD    +33 1 48 02 68 80    rachel.levy@jvr.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Rachel Levy, MD Jean Verdier Hospital
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01842295     History of Changes
Other Study ID Numbers: P110153, AOM11193
Study First Received: February 19, 2013
Last Updated: August 2, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Obesity
Bariatric surgery
Sperm quality
Fertility

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014